Thursday, March 30, 2017

The pharmaceutical industry and other interest groups have lobbied Congress to "reform" the 340B Drug Pricing Program, which they claim is riddled with waste, fraud, and abuse. Abound are damaging audits and reports that certainly back up the claim, except this over-generalization can be dangerous. Whereas hospitals are the program's primary participating vendors, there are many other smaller entities that also leverage the discounts on prescription drugs to assist their clients. No better example exists than the Ryan White covered entities, including Ryan White clinics, State AIDS Drug Assistance Programs (ADAPs), and other safety net providers.

The Health Resources and Services Administration (HRSA) summarizes the 340B Drug Pricing program as follows:

It is understandable why the drug manufacturers — most of which are required by law to to provide significant discounts (20-50%) off drug pricing— would be concerned about the growth of the program. Total sales under the program increased from $1.1 billion in 1997 to more than $7 billion in 2013,[2] and quickly climbing toward $20 billion. There are plenty of shenanigans with hospitals boosting their profits rather than providing supports and services for low-income and uninsured patients.[3] A recent study concluded, “Our findings support the criticism that the 340B program is being converted from one that serves vulnerable patient populations to one that enriches hospitals and their affiliated clinics.”[4]

Some in Congress are also alarmed. Senator Charles E. Grassley (R-IA) is chief among them, arguing a few years back, "Congress needs to know the extent to which the agency believes it lacks the statutory authority to ensure that hospitals use the 340B program to help the uninsured receive affordable prescription drugs. Medicare and private insurance are paying much more for some drugs than the hospitals paid because of the program discount. Congress needs a full picture of how hospitals are using the program and how their uses affect other programs in the health care system.”[5]

Photo Source: Brendan Smialowski/Getty Images

But there is an age-old saying, "Don't throw the baby out with the bathwater."

Earlier this year, Harish Thiagaraj authored a detailed report on how AIDS Service Organizations (ASOs) — some of which are Ryan White covered entities — have served as the poster child for the success of the 340B Drug Pricing Program. Thiagaraj accurately notes that proposed "reforms" to the program would leave such HIV entities largely untouched,[6] but there is no guarantee that harmful changes, or unintended consequences couldn't result from the programmatic reforms targeting large hospitals.

The study concludes:

"Those in the 340B industry realize that the 340B Drug Discount Program runs much more deeply than lower cost prescriptions. It provides treatment for those who are seriously ill. Its savings go towards valuable community services. Its creation was born out of necessity, and program growth directly correlates with better health and outcomes, which the Ryan White clinics’ achievements exemplify."[7]

Thiagaraj's assessment couldn't be more accurate, and we applaud him. Ryan White covered entities participating in the 340B Drug Discount Program have contributed to achieving viral suppression, and more needs to be done. The savings are re-invested back into the clinics, thereby allowing them to offer much needed supports and services to their clients.

Source: Wellpartner

That said, it is important that the integrity of the program is protected.

"The 340B program has been challenged since its inception," summarized Jeffrey R. Lewis, President and Chief Executive Officer at Legacy Health Endowment. "The challenge today is to ensure that the program is operating the way Congress intended. To accomplish this, Legacy Health Endowment will be organizing a national commission to recommend specific ways to ensure the long term solvency of the 340B program, and to determine what changes may need to be made to ensure that the program does not exceed its Congressionally mandated purpose."

Next month this issue will be discussed at the ADAP Advocacy Association's AIDS Drug Assistance Program Regional Summit in Raleigh, North Carolina. "Ryan White & 340B Drug Access" is one of the topics on the agenda with leading policy stakeholders concerned about the future of the program, and potential impact on patients living with HIV/AIDS and other underserved populations.

Wednesday, March 22, 2017

Earlier this year, we highlighted a decade of accomplishment achieved by the ADAP Advocacy Association since the organization's inception in 2007. Unfortunately, there is little time to celebrate because so much uncertainty — and yes, fear — exists over some of the troubling policies being put forth by the Trump Administration, and how they could potentially impact people living with HIV/AIDS. For that very reason, HIV advocacy must remain in motion!

Medicaid expansion — which was authorized by the ACA — had a lot to do with the dramatic decrease in the number of people uninsured in the United States. Many people living with HIV/AIDS benefited from Medicaid expansion, and their ability to access timely, appropriate care and treatment actually saved the taxpayers money. That's not to suggest that other negative, unintended consequences haven't emerged since the ACA's passage — including insurance discriminatory design with extremely high co-payments for anti-retroviral medications, adverse selection limiting access to care, or rising premiums and cost-sharing. There is also no fake news behind these facts, either!

Repeal? Replace? Repair? It is hard to know the future of the current ACA, but the Republican plan...as it currently exists...is bad for people living with HIV/AIDS. There is little debate over that statement. In fact, four Republicans governors — Snyder of Michigan, Kaisch of Ohio, Hutchinson of Arkansas, and Sandoval of Nevada —who actually favor the ACA's repeal have come out against the GOP-sponsored American Health Care Act, as it is known. Why? Because they recognize the important role Medicaid expansion has played for the people living in their respective states.

Ohio Governor John Kasich has voiced concerns about
repealing the Affordable Care Act; The Atlantic

People living with HIV/AIDS haven't been well-served by the hyper-partisanship that has swept over the nation's capitol in recent years, especially with respect to the ACA. One political party buried its collective head in the sand and ignored the law's flaws, while the other political party obsessed over repealing the law without a viable alternative to replace it. Blame can be placed at the feet of both the Democrats, and the Republicans.

But rather than trying to score political points or rehash political talking points, people living with HIV/AIDS are making their voices heard loud and clear. They are trying to be part of the solution by engaging in HIV advocacy in motion...whether is activism via social media, or the National HIV Call-In Day (which was held on March 21st), or the countless sign-on letters being sent to Congress. It is encouraging that it is happening at the national, state, and local levels.

The ADAP Advocacy Association, for its part, has a robust schedule of events and projects planned for the current year. They include:

Scholarships are available for people living with HIV/AIDS who wish to participate, so that the voice of persons living with HIV/AIDS shall always be at the table and the center of the discussion. The webinar series will include the following topics:

These activities are designed to raise awareness, offer patient educational programs, and foster greater community collaboration. Each one is enhanced by partnering with various other organizations, such as the AIDS Healthcare Foundation (AHF), Community Access National Network (CANN), North Carolina AIDS Action Network (NCAAN), and the Professional Association of Social Workers in HIV/AIDS (PASWHA). Several other projects are also in the works for the coming year.

If one good thing has come from the Trump Administration's proposed policies, then it is an increasingly energized front by the HIV community.

Friday, March 17, 2017

"I think a lot of industries are going to be coming back. We have to get our drug industry coming back. Our drug industry has been disastrous. They’re leaving left and right. They supply our drugs, but they don't make them here. To a large extent. And the other thing we have to do is create a new bidding procedures for the drug industry because they're getting away with murder.

Pharma has a lot of lobbies, a lot of lobbyists and a lot of power. And there's very little bidding on drugs. We’re the largest buyer of drugs in the world, and yet we don't bid properly. And were going to start bidding and were going to save billions of dollars over a period of time (National Public Radio, 2017)."

— President Donald J. Trump

Those two paragraphs during then-President-Elect Trump’s first
press conference on January 10th, 2017, resulted in the nine biggest pharmaceutical companies
(by market cap on the S&P 500) shedding $24.6 billion dollars in just
twenty minutes (Shen,
2017). Fox Business Network (FBN)
analysts were falling all over themselves to explain what he meant, desperate
to make it seem like he wasn’t saying that there needs to be a cap on industry
profits and to make it into an issue about taxes, regulations, and the Food and
Drug Administration (FDA) approval process (Fox Business Network, 2017). In just two
paragraphs, Donald Trump managed to place pharmaceutical companies and
lobbyists on the defensive – a position few likely thought they’d be in, after
his electoral win in 2016, as market-oriented Republicans have consistently
been sympathetic to the industry.

But breaking
beyond his rhetoric and getting at the heart of what he’s attempting to say
about the way the Federal government in the U.S. deals with pharmaceutical
pricing is no simple task, largely because the issue of pricing is cloaked from
the public as a result of existing Trade Secrets laws at both the state and
Federal levels. These laws allow
companies to keep secret how they set the price for their drugs, as well as
what and how prices are negotiated with private insurers and government payers,
like Medicaid and Ryan White Part B – the AIDS Drug Assistance Program
(ADAP). While the Centers for Medicare
and Medicaid Services (CMS) are privy to this information, the exact price that
each state’s Medicaid program pays is not public information, and releasing that
data could result in serious consequences for those programs.

Of the
three major public healthcare programs – Medicaid, the Veterans Administration,
and Medicare – only the latter is barred by law from negotiating drug prices (Kertscher,
2017). This is a result of a
provision inserted into the Medicaid Modernization Act (2003); the
act that introduced the controversial Medicare Part D. Medicare Part D is a voluntary insurance
program for prescription drugs for people on Medicare that was introduced by
former President George W. Bush that has been in place since 2006. It created a market wherein private insurance
companies offer various plans (at the county and zip-code-based levels)
subsidized by the Federal government. One of the main provisions of the Act states that, “…in order to promote
competition,” the Health and Human Services (HHS) Secretary “…may not interfere
with the negotiations between drug manufacturers and pharmacies and
prescription drug plans.”

There have
been various attempts, since 2003, to amend this part of the legislation, as it
strictly forbids the Medicare program from using its leverage to essentially
force pharmaceutical companies to provide drugs for lower prices. This leverage exists in the form of the 55.3
million Medicare beneficiaries. The 59
state and territorial Medicaid programs have used their numbers – 74.165
million – to successfully negotiate considerably larger rebates from drug
manufacturers than the private plans in Medicare Part D “…by a substantial
margin” (Department
of Health and Human Services, 2015). What differentiates Medicaid from Medicare is that the former is a
Federally-funded, state-administered program, where the latter is essentially a
model of what other nations refer to as “Universal Coverage.”

Opponents
of Medicare drug negotiation argue that allowing the largest government-funded
healthcare program to negotiate lower prices will lead pharmaceutical companies
to push for higher prices for everyone else (those not enrolled in
Medicare). They also argue that the
private insurers have greater leverage to negotiate, despite their seeming
inability to negotiate better than state governments. Others, still, argue that Medicare
negotiation is essentially anti-“Free Market,” and amounts to “price controls”
that would serve as a disincentive for drug makers to continue investing in the
research and development that produces new drugs (Cubanski
& Neuman, 2017).

What makes
now-President Trump’s two-paragraph-stock-temblor difficult for pharmaceutical
companies – not to mention “Free Market” Republicans – to swallow is that it is
entirely heretical to the “small government” line toed by modern
Republicans. That a sitting Republican
president should dare utter the belief that Big Government should be allowed to
use its leverage to “negotiate” (read: “force”) lower drug prices for Medicare
is antithetical to everything market-based Republicans and small-government
Conservatives have argued for the past forty years. And, let’s be honest: this is the kind of
stuff that made and continues to make Trump so troublesome for the Republican
Party. He’s unpredictable, often shoots
from the hip without a filter, and leaves his mess to be cleaned up by a staff
of harried, but loyal adherents who either have to step in and try to translate
what he’s said into comprehensible English, or twist themselves into human
pretzels to try and convince people that he didn’t actually say what he said, and then, explain what he was supposed
to have meant. It’s very unsettling, and
often provides political opponents enough artillery to successfully derail his
(and thereby their) agenda.

Despite
President Trump’s seeming willingness to work with pharmaceutical companies on
the issue of FDA approval procedures and regulatory issues (Johnson,
2017), both he and his media surrogates continue to float his argument for
Medicare negotiations (Daurat
& Olorunnipa, 2017). He also
faces considerable opposition from his own party – one that has made no bones
about their opposition to the idea. To
their way of thinking, the private sector is better suited to negotiate lower
prices, rather than Big Government coming in to tell them what they can charge. His Secretary of Health and Human Services,
Tom Price, has, in the past, been consistent in his opposition to Medicare drug
negotiations and has repeatedly blocked measures that would allow the HHS to do
so. In his confirmation hearings,
however, he stated that his “boss will be the President of the United States,”
in response to questions on the subject. While not an overt statement in support, it came across as more of a
resignation that that’s what Trump wants, despite his own wishes.Congressional Republicans even have
some evidence to back up their claims. The Congressional Budget Office (CBO) has indicated that competition
among plan sponsors in Medicare Part D markets has led to lower costs (Congressional
Budget Office, 2014). The caveat is
that those savings are largely seen only in regions where there are a large
number of sponsors – essentially, places where there is a market for their
services: areas where retirees have higher incomes. Part of the reason why Medicare Part D has
come in at a lower price tag than the CBO initially projected is that
enrollment is 12% lower than expected (CBO). Advocates of Medicare negotiation have
suggested that this lower enrollment is due to people in smaller markets being
unable to afford the monthly expenditure for Part D coverage, as well as the
fact that the prices in those smaller markets’ plans simply aren’t low enough
to make the plans attractive. Essentially, “Why buy something you can barely afford only to still be unable to afford your
medications?”There’s little question that the coming
year is likely to produce many questions about President Trump’s assertion that
the drug companies are “getting away with murder,” especially as his positions
continue to be amorphous. What this will
mean for Medicare has yet to be seen, but you can bet that whatever it is, it
will leave critics and proponents, alike, trying to figure out how they got
there.Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Thursday, March 2, 2017

The rising cost of prescription drugs is on everyone's mind, and the issue is increasingly being scrutinized by the executive and legislative branches inside the Beltway. Even President Donald J. Trump has raised the issue over prescription drugs costs — though it typically ins't a signature Republican issue — and Senator Bernie Sanders (I-VT) has recently introduced legislation to allow drug importation. The debate over drug importation is a complex one, often muddled by talking points by both sides.

Here is how the American Association of Retired Persons (AARP) defines drug importation:

"Drug re-importation refers to the practice of importing back to the United States prescription drugs that were originally manufactured in the U.S. and exported for sale in another country. Most often, Americans re-import drugs for personal use by filling their prescriptions in Canadian or Mexican pharmacies, either in person, or through mail-order or Internet pharmacies."1

Proponents of the drug importation cite the need for consumers to access less expensive prescriptions drugs. According to a relatively recent national survey commissioned by Gallup, "27% of Americans name cost as top health problem."2

The U.S. Food & Drug Administration (FDA) found that one in ten Americans cannot afford their prescription drugs. That same study found approximately 1.6% of consumers have bought prescription drugs from another country.[3]

“There is no reason why drug importation should be a problem for the United States," said Eddie Hamilton of the ADAP Educational Initiative based in Ohio. "Generic Abacavir is already being imported into the U.S. from India for domestic patients by ADAPs without issue.”

Photo Source: Huffington Post

The Sanders legislation is only latest attempt by Congress to allow drug importation. It has also gained support from some colleagues — Senators Cory Booker (D-NJ) and Bob Casey (D-PA) — in the Senate who had previously opposed drug importation legislation.

Though AARP hasn't yet endorsed the Sanders legislation (S.469), similar legislation did receive support from the organization. In 2009, AARP Senior Vice President David Sloane argued: “AARP is committed to helping our members and all older Americans have greater access to and reduced costs for the prescription drugs they need, including both through safe importation and other important measures such as closing the dreaded coverage gap in Medicare Part D known as the ‘doughnut hole.’"[3]

Senator Sanders isn't alone in his fight over drug importation, because Senator John McCain (R-AZ) has also introduced similar legislation. The McCain legislation (S.92) has bipartisan support, unlike the Sanders legislation.

Opponents have equally strong arguments against drug importation. Among them, concern over drug safety, including counterfeit or black market drugs. In 2014, a new resource for the HIV/AIDS community and their doctors was made available by the Community Access National Network (CANN) and Partnership for Safe Medicines. The resource, "Black Market HIV Drugs in the News, 2006-2013," sought to increase awareness of the severe health risks posed by counterfeit or black market medicines.[4]

Summarized Bill Arnold, CANN's President & CEO, who continues to have doubts about drug importation: "The importation or re-importation of medications from outlets other than those regulated by the FDA and other U.S. authorities is particularly dangerous for the HIV-positive patient. In the past, anti-retroviral drugs from this grey, or black, market system have turned up in many places. These drugs have turned out to be completely fake, improper potency, contaminated, and worse."

The Pharmaceutical Research and Manufacturers of America (PhRMA), who also opposes drug importation, has been very local about pitfalls over the potential lack of drug safety. The issue is characterized as "unsafe and lead to potentially dangerous outcomes for patients."[5]

PhRMA will host a policy briefing on the issue. The briefing, "Safety and the Supply Chain: Ensuring Prescription Medicines are Safe for Patients," will discuss the important role of the FDA in ensuring the safety of medicines from test tube to patient, the threat of counterfeit drugs to patient safety, the importance of the Drug Supply Chain Security Act and the implications of drug importation proposals. It is open to all interested stakeholders, but advance registration is required.[6]

It appears that Senator Sanders anticipated the pushback over drug safety, because his legislation requires foreign sellers to register with the FDA, as well as other safety measures. The add-ons should alleviate some concerns, but not all of them.

The ADAP Advocacy Association has also traditionally opposed drug importation, but it remains open to dialogue on the issue. Like most public policy issues, there is no easy answer or solutions. To that end, drug importation will be part of the conversation during our 10th Annual Conference later this year.